Abcellera Biologics Inc., of Vancouver, British Columbia, published preclinical data on bamlanivimab (LY-CoV555), a monoclonal antibody targeting SARS-CoV-2, in Science Translational Medicine. X-ray crystallography and electron microscopy showed bamlanivimab binds to the spike protein in an area that overlaps the ACE2 binding site in both the up and down positions. In nonhuman primates, doses of 2.5 mg/kg and higher serum concentrations produced maximum reduction of viral replication as well as viral load in the upper respiratory tract.
AIkido Pharma Inc., of New York, was granted an exclusive sublicense to technology related to the use of central nervous system homing peptides for the therapeutic treatment of neuroinflammatory disease in cancer patients. The peptides can be used for delivery of therapeutic agents to inflamed tissue. Terms were not disclosed.
Akili Interactive Inc., of Boston, disclosed collaborations with Weill Cornell Medicine, New York-Presbyterian Hospital and Vanderbilt University Medical Center to evaluate digital therapeutic AKL-T01 as a treatment for patients with cognitive dysfunction following COVID-19. There are no approved treatments for cognitive impairments in COVID-19 survivors. Under each collaboration, Akili will work with research teams at each institution to conduct two separate randomized, controlled clinical studies evaluating the compound.
Alkermes plc, of Dublin, signed a clinical trial collaboration and supply agreement with Merck & Co. Inc., of Kenilworth, N.J., for a planned phase III study to evaluate nemvaleukin alfa, Alkermes' investigational engineered interleukin-2 variant immunotherapy, in combination with Merck’s Keytruda (pembrolizumab), in comparison to investigator choice chemotherapy in patients with platinum-resistant ovarian cancer. Alkermes is responsible for conducting the study, which is expected to start in the second half of this year.
Covimro Ltd., of London, in September of last year demonstrated effectiveness of its food-grade compound, Covimro, against the coronavirus. More recently, the same compound has been shown to be equally effective against other viruses, the company said. Covimro was tested for antiviral efficacy against lentivirus/HIV with a luciferase assay, and results show a 3-log reduction in viral titer at all concentrations tested.
Cytodyn Inc., of Vancouver, Wash., which is developing leronlimab (PRO-140), a CCR5 antagonist with potential multiple therapeutic indications, executed an exclusive supply and distribution agreement with Biomm SA, of Sao Paulo, Brazil. The deal lets Biomm sell leronlimab in Brazil following regulatory clearance. Cytodyn has committed to conduct trials in Brazil for all current indications for the compound.
Elevation Oncology Inc., of New York, published preclinical data on seribantumab, a monoclonal antibody targeting HER3, in Clinical Cancer Research. NRG1 fusion models seribantumab produced tumor regression of 50% to 100% at levels below the equivalent human dosage being tested in clinical trials. Elevation is currently testing seribantumab in the phase II Crestone study of patients with solid tumors with an NRG1 fusion.
Endevica Bio Inc., of Columbia, Mo., formerly known as Tensive Controls Inc., said it signed an agreement with Wuxi Apptec to begin toxicology studies for TCMCB-07, a peptide therapeutic for cancer cachexia. TCMCB-07 is a potentially first-in-class melanocortin 3/4 antagonist peptide designed to reduce pro-inflammatory cytokine gene expression in the brain and to effectively cross the blood-brain barrier. Endevica expects to file an IND by the first quarter of 2022.
Evgen Pharma plc, of Cheshire, U.K., said a preprint publication from Johns Hopkins University demonstrates that sulforaphane, the active ingredient in SFX-01, prevents virus-induced cell death in vitro induced by several variants of the SARS-CoV-2 virus and another coronavirus. Data showed that the inhibition of SARS-CoV-2 cytotoxicity by sulforaphane occurs both when cells are pretreated with sulforaphane and when sulforaphane is administered 24 hours after viral inoculation. The work also shows that sulforaphane acts synergistically with the antiviral drug remdesivir (Gilead Sciences Inc.). The authors further established that the effects of sulforaphane, administered orally, were observed in vivo in a mouse model infected with the SARS-CoV-2 virus, where reduction in both viral load and lung pathology were observed.
IMV Inc., of Dartmouth, Nova Scotia, said following FDA feedback, the company entered an agreement with Merck & Co. Inc., of Kenilworth, N.J., to initiate a phase IIb trial testing IMV’s lead compound, maveropepimut-S (DPX-Survivac) in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with recurrent/refractory diffuse large B-cell lymphoma. The contribution of low-dose cyclophosphamide as an activator of immune response will also be evaluated. The study is expected to begin in the second quarter of 2021.
Intravacc, of Bilthoven, the Netherlands, reported preclinical data from its SARS-CoV-2 outer membrane vesicle (OMV)-based recombinant spike protein (rSp) candidate nose spray vaccine, showing that, in mice that received either the CovOMV or CovOMVclick vaccines, respectively, 30% and 90% virus neutralizing antibodies were detected. In hamsters, both candidates induced neutralizing antibodies, but the level of antibodies in the CovOMVclick group was slightly higher. Intranasal vaccination with both candidate vaccines resulted in complete protection after challenge. CovOMV is based on OMV mixed with rSp, while CovOMVclick involves a vaccine based on OMV that is coupled to rSp based on Intravacc’s click technology.
Kamada Ltd., of Rehovot, Israel, disclosed an amendment to its deal with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, for Glassia (alpha proteinase inhibitor [human]). Pursuant to the amendment, upon completion of the transition of Glassia manufacturing to Takeda, expected by the end of 2021, Kamada will transfer to Takeda the Glassia U.S. BLA. In consideration for the BLA transfer, Kamada will receive a $2 million payment from Takeda. In addition, the payment by Takeda of the final sales-based milestone of $5 million due to Kamada under the license agreement was accelerated, and the company anticipates it will be able to recognize that milestone during 2021. The parties have agreed to continue to share product-related information and data following the BLA transfer. There are no other material changes to the existing license agreement.
Luca Science Inc., of Tokyo, said it expanded its operations, with a new subsidiary in in the U.K., and will focus on research collaborations with the University of Oxford using its mitochondria therapy in advancing treatment of intra-uterine growth restrictions (IUGR) for mothers and babies. Currently, IUGR is treated by delivery irrespective of gestation. The collaboration is focused on addressing IUGR by specifically delivering therapeutics to the placenta.
Mydecine Innovations Group, of Denver, disclosed its four lead drug candidates, as it prepares for pre-IND meetings with the FDA and Health Canada. The company is working on MYCO-001, a pure psilocybin derived from natural fungal sources; MYCO-002, an entactogenic compound designed to improve safety profile vs. traditional MDMA; MYCO-003, a psilocybin-based formula with reduced anxiety potential; and MYCO-004, a patch delivery tryptamine.
Oxurion NV, of Leuven, Belgium, said a review article published in Progress in Retinal Eye Research describe how RGD integrins affect a multitude of disease-related proteins and molecular pathways in relation to retinal vascular disorders. Based on those findings, the authors conclude that therapies that engage integrin-linked pathways, including THR-687, have the potential to block all of those pathways and to deliver clinical benefits to patients ocular diseases such as diabetic macular edema (DME) and neovascular age-related macular degeneration. THR-687 is on track to enter a phase II study in DME and mid-2021.
Protokinetix Inc., of Marietta, Ohio, said a paper published in the Journal of Tissue Engineering and Regenerative Medicine describes and interprets results examining the benefit provided by AAGP, its anti-aging glycopeptide, to enable human induced pluripotent stem cell-derived retinal precursor cells. Data showed cells treated with AAGP showed threefold greater improvement in electroretinography and optokinetic tracking, while cells transplanted without AAGP offered no benefits. More transplanted cells also survived long term in the retina, and only AAGP-treated cells showed maturation and integration with the host retina.
Psioxus Therapeutics Ltd., of Oxford, U.K., said it updated an agreement to advance its clinical collaboration with Bristol Myers Squibb Co., of New York, to evaluate the safety, tolerability and preliminary efficacy of Psioxus’ tumor re-engineering platform, in combination with BMS’ PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), to treat a range of tumor types in late-stage cancer patients. The first stage of the collaboration combined Opdivo with Psioxus’ enadenotucirev in the phase I Spice study, and the revised collaboration with build upon those initial study data and combine Opdivo with Psioxus’ NG-641, a tumor re-engineering product using Psioxus’ Tumor-Specific Immuno-Gene Therapy platform based upon the enadenotucirev vector. Under the terms of the agreement, Psioxus will be responsible for conducting the phase I study, with patient recruitment expected to start in the third quarter of 2021.
Rigel Pharmaceuticals Inc., of South San Francisco, said it closed its license agreement with Eli Lilly and Co., of Indianapolis. The companies entered the potential $960 million global exclusive license deal and collaboration to co-develop and commercialize Rigel’s R-552, a RIPK1 inhibitor, for all indications, including autoimmune and inflammatory disease.
Shanghai Genechem Co. Ltd., of Shanghai, said it executed a global collaboration with I-Mab Biopharma Co. Ltd., also of Shanghai, to develop and commercialize multiple bispecific antibodies based on monoclonal antibody developed by Genechem and antibodies selected by I-Mab. Terms were not disclosed.
Silo Pharma Inc., of Englewood Cliffs, N.J., said it finalized an agreement to sublicense the technology covered by its recently announced provisional patent applications filed with the U.S. Patent and Trademark Office, pertaining to its CNS homing peptides for use in the therapeutic treatment of pain from neuroinflammation in cancer patients.
Soligenix Inc., of Princeton, N.J., said the FDA conditionally accepted Hybryte as the proposed brand name for SGX-301 (synthetic hypericin), the company’s photodynamic therapy for first-line treatment of early stage cutaneous T-cell lymphoma. Soligenix is focused on submitted a rolling NDA for the drug in the second quarter of 2021.
Stealth Biotherapeutics Corp., of Boston, disclosed in its fiscal year 2020 earnings April 6 that its NDA submission for elamipretide for cardiomyopathy in Barth syndrome might be delayed based on recent FDA feedback and ongoing interactions. During meetings with the agency’s Division of Cardiology and Nephrology earlier this year, the FDA expressed its view that the existing clinical data are insufficient to demonstrate substantial evidence of effectiveness and do not support NDA review. The FDA suggested potential paths forward to generate additional data, including by a randomized withdrawal of therapy from patients in the company's ongoing open-label extension trial and from additional potential patients the company could enroll. Stealth said it is evaluating the proposed withdrawal protocol among other potential next steps. In late 2019, Stealth reported that elamipretide failed to hit its endpoints in a phase III trial in another mitochondrial disease, primary mitochondrial myopathy. The drug also is being tested in dry age-related macular degeneration with geographic atrophy, with data from a phase II study expected in the first half of 2022.